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United States · US · US:42023-500_6d6942ec-d208-4ea6-9ad4-ef4b29aca966

Adrenalin (epinephrine in sodium chloride)

In shortageOrange BookUNIISPLATC R03AA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4202350010
    10 BAG in 1 CARTON (42023-500-10) / 250 mL in 1 BAG (42023-500-01)

Annotations

UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N215875
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "YKH834O4BH",
    "rxcui": "3992",
    "inchikey": "UCTWMZQNUQWSLP-VIFPVBQESA-N",
    "display_name": "EPINEPHRINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a5ce0c01-dd47-4997-ab09-490de65d3835": {
      "match": "brand_token",
      "title": "ADRENALIN (EPINEPHRINE) INJECTION [PAR HEALTH USA, LLC]",
      "spl_version": "10",
      "published_date": "2026-04-22"
    }
  },
  "productid": "42023-500_6d6942ec-d208-4ea6-9ad4-ef4b29aca966",
  "productndc": "42023-500",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215875",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG/250ML (8MCG/ML)",
        "product_no": "001",
        "approval_date": "Apr 21, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG/250ML (16MCG/ML)",
        "product_no": "002",
        "approval_date": "Apr 21, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG/250ML (20MCG/ML)",
        "product_no": "003",
        "approval_date": "Apr 21, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "8MG/250ML (32MCG/ML)",
        "product_no": "004",
        "approval_date": "Apr 21, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/250ML (40MCG/ML)",
        "product_no": "005",
        "approval_date": "Apr 21, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE",
  "shortage_reason": "Epinephrine Injection",
  "shortage_status": "current",
  "proprietary_name": "Adrenalin (epinephrine in sodium chloride)",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA215875",
  "marketing_category": "NDA",
  "nonproprietary_name": "Epinephrine in Sodium Chloride",
  "start_marketing_date": "20250519",
  "active_numerator_strength": "32"
}

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